Developing and Testing of Meaningful MultimodalSensory Stimulation in patients with Coma following Traumatic Brain Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- (CRS-R)
研究概览
简要总结
After briefing about demographic variables,
| Patients will be screened depending upon the inclusion criteria. An informed consent to participate in the study will be taken from the guardian of the patients . Provision for re-consent will be made once the patient is cognitively capable. The patients will be allocated to 2 groups ie) control group and experimental group. Block randomization method will be used for allocation. |
Control group will be administered with the conventional coma arousal technique that uses various stimuli viz.) music for auditory stimulation, photos for visual stimulation, touch for tactile stimulation, familiar smell as olfactory stimulation etc. single stimuli or a combination of them will be used .
Experimental group will be administered with the newly developed therapy –“Meaningful multimodal coma stimulation technique†A detailed history about likes and dislikes of the patients will be taken. Depending upon it , a functional task will be made for the patient that includes various stimuli like auditory ,tactile, proprioceptive, gustatory etc. taking into consideration its meaningfulness and feasibility eg) Patient will be made to sit in a wheelchair, will be made to feel the texture and shape of orange (tactile) will be made to look at the orange(visual stimuli) will be made to peel the orange and smell it (olfactory stimuli) dipping a cotton ear-bud in orange and pressing it on tongue patient will be made to appreciate its taste (gustatory stimuli). Various functional tasks that includes all the stimuli or a combination of them will be used for the patient.Duration of each stimuli will be 5-15 minutes depending upon patients response.
Duration of treatment will be same for both the groups – 45 minutes thrice a day for 2 weeks .CRS-R and SSAM scores will be taken at the time of admission (48 hours after traumatic brain injury in case of medically managed patients and 48 hours after operation in case of surgically managed patients), end of 1st week and end of 2nd week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Who are haemodynamically stable and shifted out of ICU, have a GCS score less than 8, and minimum of 48 hours after surgery or conservative management.
排除标准
- •Who have a previous history of Brain Damage,known case of impaired vision and hearing,active Otorrhoea or Rhinorrhea (signs of CSF leak),Coma or persistent vegetative state not caused by TBI,patients with autonomic dysfunction and unstable Long bone fracture, associated injuries.
结局指标
主要结局
(CRS-R)
时间窗: 1 st day, end of 1st week and end of 2nd week
Coma recovery scale revised
时间窗: 1 st day, end of 1st week and end of 2nd week
次要结局
- Sensory stimulation Assessment Measure (SSAM)(1 st day, end of 1st week and end of 2nd week)